Humacyte’s ATEV Evaluated for AV Access in Hemodialysis in Phase 3 Trial

July 31, 2024—Humacyte, Inc. announced top-line results from the V007 clinical trial of the company’s acellular tissue engineered vessel (ATEV) in arteriovenous (AV) access for patients with end-stage renal disease. Detailed results to be presented at upcoming medical conferences, noted the company.

In the trial, ATEV demonstrated superior function and patency at 6 and 12 months (coprimary endpoints) compared to autogenous AV fistula, which is the current standard of care for hemodialysis patients. ATEV is a bioengineered human tissue designed to be a universally implantable vascular conduit for use in vascular replacement and repair and for use as hemodialysis access.

According to Humacyte, V007 is a phase 3, prospective, multicenter, randomized clinical trial composed of 242 hemodialysis patients in the United States. The patients were randomly assigned to receive either the ATEV or an autogenous AV fistula for hemodialysis access. They are being followed for up to 24 months.

Under the statistical analysis plan for the trial, the primary efficacy assessment compared functional patency (usability for hemodialysis access) at 6 months and secondary patency (blood flow through the conduit) at 12 months, as coprimary endpoints.

As summarized in the company’s press release, the results included the following:

• At 6 months, functional patency was achieved in 81.3% of the patients implanted with the ATEV versus 66.4% of the patients receiving an AV fistula.
• At 12 months, secondary patency was achieved in 68.3% of the patients implanted with the ATEV versus 62.2% of the patients receiving an AV fistula.
• At 6 and 12 months, the joint test for superiority of the ATEV versus the AV fistula was statistically significant (P = .0071).
• In the first 12 months, patients receiving ATEV achieved a significantly longer duration of hemodialysis versus patients with AV fistula (P = .0162).
• More adverse events were reported in patients on the ATEV treatment arm than those on the AV fistula treatment arm.

Humacyte’s ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. As previously announced, based on guidance from the FDA, the proper or generic (nonbrand) name “acellular tissue engineered vessel,” or ATEV, has replaced the term “human acellular vessel,” or HAV, that was previously used for Humacyte’s bioengineered vessel candidate, advised the company.